Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Transcriptional changes in gut microbiota present in stool.
研究概览
简要总结
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
详细描述
The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between (and including) 18-65 years old.
- •On a baseline healthy diet characterized by:
- •High fiber of ≥ 14 g/1000 calories/day
- •< 10% of daily calories from added sugar
- •At least 5 servings of fruit and vegetables per day
- •< or = 13% of daily calories from saturated fat
排除标准
- •Patients who do not meet the above diet requirements.
- •Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
- •Presence of abdominal symptoms based on baseline questionnaire.
- •Commercial oral antibiotic or probiotic use within the past 4 weeks.
- •Pregnancy or plans to become pregnant within the study time frame
- •Vulnerable adults
- •Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
结局指标
主要结局
Transcriptional changes in gut microbiota present in stool.
时间窗: Baseline, approximately three weeks.
DNA extraction from stool samples will be done using standard assays.
次要结局
未报告次要终点
研究者
Purna C. Kashyap, MBBS
Principal Investigator
Mayo Clinic